HS-IRBs News July 2013

Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 7, July 2013

Upcoming IRB for Beginners Workshops

The HS IRBs office is offering another round of the IRB for Beginners Workshops. The 90-minute workshop will be held in the HSLC computer lab and will give participants a first-hand view of the resources available on the HS-IRBs website as well as basic tools and tips for the ARROW electronic application submission system.  The workshop will also introduce participants to the IRB’s review process and procedures.  This workshop is designed to help people who are new to the HS-IRBs review process.

This workshop is scheduled for the following dates:


Wednesday August 21st  2:30 - 4:00 PM (HSLC Room 2121)

Monday September 23rd  9:00 - 10:30 AM (HSLC Room 2121)

Registration is required. Please email Brooke Mechelke at bmechelke@medicine.wisc.edu to reserve your spot in one of the future sessions.  Space is limited. NOTE: The previously announced August 15th workshop is full and registration is now closed for that session.

CITI Training Outage Starting July 29th

CITI is the program used by UW-Madison to offer human subjects research and other training courses. The University of Miami will be updating the CITI Program interface and UW-Madison users will be unable to access CITI for several days beginning Monday, July 29. During this time, UW-Madison users will be unable to complete CITI courses, including human subjects research, stem cell, and effort reporting training.

Any courses completed prior to 6:00AM on Monday, July 29th, should be visible to UW-Madison personnel in the Graduate School's lookup system (https://my.gradsch.wisc.edu/lookups/citi/trainingStatus.html). IRB submissions with key personnel who have not completed human subjects research training or have expired training may experience delays in the IRB review process during the CITI outage.

If you have questions about how this outage may affect your HS-IRBs submissions, please contact asktheirb@medicine.wisc.edu.

Revised Business Services Policy on Payments to Research Participants

The UW’s Business Services has updated its policy on Payments to Research Participants. This policy outlines the payment mechanisms that can be used to pay subjects and when gathering tax information from research participants is required. Of note, this policy clarifies that if information, such as Social Security Number, will only be collected to pay subjects and not for the research study otherwise, this information does not need to be disclosed in the consent and HIPAA authorization documents. If study teams are required to collect tax information from subjects, they are recommended to have participants complete a form, which is maintained separately from research records, to obtain relevant information and that also alerts the participant that the payment will be reported by the UW to the IRS.

New Guidance on Completing Protocol Development Activities (PDAs) Applications

New guidance has been posted on Completing the Protocol Development Activities Applications (PDAs)  to assist study teams in filling out the PDA application in ARROW. Study teams also are encouraged to review the Protocol Development Activities (PDA) Guidance .

Revised Personnel Change Guidance

In response to feedback from researchers, the Personnel Change Guidance has been revised to clarify how and when to report to the IRB when a Principal Investigator (PI) goes on temporary leave. The guidance now clarifies the following:

  • For shorter periods of leave or vacation (i.e., less than 1 month), the PI is responsible either for ceasing study activities or ensuring oversight of these activities is delegated to an appropriately qualified member of the study team.  In such cases, no reporting to the IRB is necessary.
  • For a temporary leave by the PI of 1 month or longer (e.g., sudden illness, parental leave, military service),the study team is required to submit a New Information Report to the IRB that:
    • confirms no study activities will occur during the PI's leave;
    • confirms that only activities involving data or sample analysis will occur during the PI's leave; OR
    •  identifies who will assume PI responsibilities for the study during the leave. 
For PI leaves of longer than 1 month, the New Information Report should be provided to the IRB as soon as possible, preferably before the PI takes leave.  A second New Information Report should be submitted to the IRB when the PI resumes his or her role as PI.  If the PI cannot return from leave or changes his or her role after the leave ends (e.g., becomes a sub-investigator), the study team must submit a change of protocol to formally change the PI for that protocol.

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.

  • For urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
  • For general IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email asktheirb@medicine.wisc.edu. These are the quickest ways to get help with general questions.
  • For assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • To receive updates about WIRB, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
  • Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
  • Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.

Keywords:newsletter, workshops, human subjects research training, CITI, payment, social security, PDA, protocol development activities, personnel change, PI, principal investigator, leave   Doc ID:31763
Owner:Carol P.Group:Health Sciences IRBs
Created:2013-07-23 14:45 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
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